Odds are high that most realize that a successful Kevetrin trial isn't guaranteed at this stage due to mouse studies. Most are encouraged by the number of cohorts along with some tumour reduction. Kevetrin making it to a 10th cohort without the trial being stopped from toxicity is momentous in itself when you look at past trials in this arena. The primary endpoint of safety in the Kevetrin phase 1 appears likely to be met. There has been a lot of unsuccessful research dealing with p53 in the past and that is what creates doubt. Roche and the toxic nutlins come to mind.
The fact that there has been tumour shrinkage in this phase 1 trial is also quite encouraging. Many are watching closely for the final results. Especially, patients that may want to enter the phase 2 Kevetrin trial.
Brilacidin has derisked this investment as it has been moved forward in trial. The dose optimization of the 2b was brilliant since it appears to have solved the issues from the earlier 2a. And, that one dose vs 7 dose of daptomycin can't be ignored. Patient compliance won't be an issue and hospital stays will be shortened.
In Reply to 'To infinity and beyond!'
Interesting reading. Many posts suggest the previous research and previous trials in mice etc guarantee success for Kevetrin. Somewhere there is a good summary article that details all the various stages where once very promising drugs failed, but I cannot see taking the time to find it because I thought it to be common knowledge. Of course the drug can still fail.
Now though is an exciting time to be watching CTIX since things are picking up : setting doses and actually enrolling patients then seeing if K really helps cancer pts.
Plenty of anti physician sentiment out there, unsure why. I would assume that I am neither smarter nor dumber than all of you, and I would never suggest otherwise. At this stage in my life(57) I find that I am enamored less of smarts and more of effort, and hard work.
At some point I hope to be of some value to the board, based on seeing patients most days with celllulitis, and I will be able to tell you the buzz on Brilacidin, and whether the Infectious Disease consultant is sticking with Vancomycin and why, etc. And I would hope to see patients in the ED on K, such as the woman I saw yest with ovarian CA, widely metastatic, and struggling.
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